FDA grants priority review to KTE X 19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. Kite/Gilead.

Kite, a Gilead Company announced that the FDA has accepted the Biologics License Application (BLA) and granted Priority Review designation for KTE X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The BLA is supported by data from the single arm, open-label, Phase II ZUMA-2 trial, which showed that 93 percent of patients responded to a single infusion of KTE X19, including 67 percent of patients achieving a complete response, as assessed by an Independent Radiologic Review Committee (IRRC; median follow-up of 12.3 months). In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred. Detailed findings from this trial were recently presented during an oral session at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando.